The National Health Surveillance Agency (ANVISA) plays a vital role in Brazil, regulating products and services related to health. In an ever-evolving world, regulatory compliance is the backbone of patient safety and business success. When it comes to regulatory compliance, choosing the right Hosting Service is crucial.
In the recent past, it was common for foreign manufacturers to delegate this strategic function entirely to their local distributor. However, over time, it became evident that the consequences of this choice could be very costly for the manufacturer. During these last three decades of regulatory consulting, we at Brisa Advisors have witnessed cases of manufacturers being pushed out of the market due to commercial conflicts with their distributors. Some were unable to expand their distributor networks, missing out on significant market opportunities. We’ve seen instances of techno-vigilance where distributors chose to defend themselves before ANVISA instead of the manufacturer’s interests. We even followed a case where a competing manufacturer acquired the local distributor, holding the registrations of their global competitor, and canceled existing ANVISA registrations, taking that player out of the Brazilian market for several years and capturing their market share.
Professional Hosting Service options emerged back in 2003 with the publication of RDC No. 1 on January 6, 2003. This resolution regulated the Importation of Goods by companies without product regularization documents before ANVISA, through a declaration from the company holding the registration authorizing another importer to use its registration. Since then, many consulting companies have established import companies with the goal of hosting medical device registrations in Brazil.
Amidst numerous options in the market, it’s important to consider some key points:
1. How many years of regulatory market experience does the company have?
2. Financial stability.
3. Ability to transfer ownership at any time as specified in the contract.
4. Secure Document Storage: ANVISA requires companies and organizations to submit regulatory documentation for product approval or registration. A hosting service should offer secure and reliable storage for these documents, ensuring they are accessible and protected.
5. Compliance with Brazilian Regulations: The hosting service must comply with relevant Brazilian regulations, such as ANVISA standards, to ensure that the stored data and documents align with legal requirements.
6. Data Security: ANVISA deals with sensitive health-related information. Therefore, data security is critical. Ensure that the hosting provider has stringent data security measures in place, including encryption, user authentication, and access control.
7. Data Backup and Recovery: Having an effective data backup and recovery strategy is important to ensure that regulatory documentation is not lost in the event of hardware failure or other incidents.
8. Availability and Performance: The availability and performance of hosting systems are essential to ensure that documents can be accessed and submitted to ANVISA in a timely manner, especially when dealing with regulatory deadlines.
9. Specialized Technical Support: It is important that the hosting provider has knowledge and experience in dealing with ANVISA regulatory matters to provide proper technical support and assistance in resolving compliance-related issues, as well as supporting INMETRO and ANATEL certifications.
10. Audit and Tracking: The ability to audit and track activities related to regulatory documents is crucial to comply with compliance requirements.
Whether you are seeking product approval, assistance in maintaining compliance, or simply want to better understand the ever-changing regulatory landscape, we are here for you.
At Brisa Advisors, we understand the challenges you face, and we are committed to simplifying this challenge for you!
Contact us today and discover how we can be your trusted partner in regulatory affairs.
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*Schedule a meeting at MEDICA Düsseldorf, Germany 13 – 16 November 2023
* Budget for the registration ownership transfer, Market Access Strategy and BPO in RA services for your company: www.brisa.com.br
